Inside-out guide for hip replacement method

ABSTRACT

A tool and method for locating a proper position for a portal incision for hip arthroplasty, the tool being a tubular body having a first portion defining a first axis, a second portion defining a second axis non-parallel to the first axis, the second portion having a directional tool and a lead coaxially aligned, wherein when the tubular body is placed adjacent to an acetabulum with the directional tool aimed at the acetabulum and perpendicular to a plane of the face of the acetabulum, the lead points to location on the skin that would be the proper location for the portal incision. The lead may have a blunt tip, a cutting instrument, or an opening through which a flexible tool can be inserted to forge a path towards the proper location for the portal incision.

CROSS-REFERENCES TO RELATED APPLICATIONS

This patent application is a divisional of U.S. patent application Ser.No. 13/440,962, filed Apr. 5, 2012 (now U.S. Pat. No. 9,439,675), whichis a continuation-in-part application of U.S. patent application Ser.No. 13/431,944, filed Mar. 27, 2012, entitled “Precision Hip ReplacementMethod,” which claims the benefit of U.S. Provisional Application No.61/528,744, filed Aug. 29, 2011, and U.S. Provisional Patent ApplicationNo. 61/567,869, filed Dec. 7, 2011. All applications are incorporatedherein by this reference thereto.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to the field of minimally invasive surgicaltechniques for a joint replacement, and more particularly, methods foraccurately positioning components for hip or knee joint replacementprocedures.

Description of the Related Art

During the course of total hip arthroplasty, acetabular and femoralprostheses are placed. In order for the implants to function up to theircapacity, generally meaning greater than twenty (20) years of clinicalreliability, each component must be placed in a specific position inrelation to the patient's native anatomy. Specifically, properpositioning of the acetabular component in a hip replacement procedureappears to be crucial to the long-term success of the surgery. Whatexactly constitutes proper positioning of the acetabular component isthe subject of much debate. A commonly used range, established byLewinnek et al., involves a cup position in which the abduction angle iswithin the range of 30° to 50° and in which the anteversion angle iswithin the range of 5° to 25°. Generally, surgeons use radiographictechniques to achieve these angles.

Studies have shown, however, that a substantially large percentage ofsurgeries result in cups that are not within this range. This isespecially true with respect to minimally invasive surgical procedures.Callanan et al. surveyed 1952 hip replacements, observing severalprediction factors, and found that only 48.7% resulted in acetabularcups within this range. Indeed, of the 93 hip replacements in Callanan'ssurvey that used minimally invasive techniques, only 19.4% resulted inacetabular cups within this range.

This supports the proposition that traditional techniques have beenconsidered by many to be unreliable for determining proper positioningof the acetabular cup or femoral component.

A variety of tools are available, however, to assist the surgeon inachieving correct component alignment. The so-called traditional guides,or line-of-sight, have been in use for over 40 years and are veryhelpful, but not as reliable as one would hope.

In the last 8-9 years, in an effort to improve reliability, there havebeen attempts at using so-called navigation or computer guidance systemsrelying on pre-operative CT scans to pre-load information pertaining tothe patient's anatomy, intraoperative registration (a cumbersome andpotentially tedious method to match the patient's anatomy to thepreloaded image), the placement of multiple skeletal pins fororientation, and elaborate line-of-site transmitters relying on complexcomputer algorithms to guide component placement. Unfortunately, inspite of the promise of improved results, the reluctance of patients tobe exposed to a significant amount of radiation during a CT scan, thesignificant cost of such a test against a simple intraoperative x-raytreatment, the total cost of the computer guidance system (many hundredsof thousands of dollars plus the ongoing cost of support annually as themachine is maintained and updated), the incalculable cost to thehealthcare system, and the patient of an unpredictable workflow assystem breakdown occurs frequently, add operation time and potentialrisk to the patient, as well as considerable cost. Consequently, thismethod has not been widely adopted.

Furthermore, in spite of the existence of such tools, the currentsuccess rate for acetabular component positioning is only sixty percent(60%). Therefore, there is still a need to improve the reliability andefficiency of instrumentation in achieving these specific recognizedoptimal component positions.

SUMMARY OF THE INVENTION

One embodiment of the present invention comprises methods for accuratelypositioning the acetabular cup in a minimally invasive, or conventional,total hip arthroplasty (THA), comprising the use of an elongated handleto place the cup in roughly the correct position with respect to theacetabulum of the patient, taking a first abduction reading and a firstanteversion reading using a gyroscopic positioning unit aligned with thehandle, taking an image of at least a portion of the cup using aradiography unit, using the image to determine the actual orientation ofthe cup and thereby the amount of movement in the abduction plane and inthe anteversion plane to properly orient the acetabular component,incrementally altering the position of the cup by using a striking tooland an elongated instrument to tap a contact surface at one or morepreformed impact receiving points, wherein the contact surface is inmechanical communication with the cup, taking new abduction andanteversion readings using the gyroscopic unit to determine the relativemovement of the cup caused by the tapping, and repeating this strikingstep and this reading step until the cup has proper abduction andanteversion readings.

In another embodiment of the present invention, the surgeon may takeadditional intra-operative radiographic images during this process asneeded. Other embodiments may also involve taking readings from a secondgyroscopic unit aligned with a point on the pelvis so that any movementof the pelvis in any direction during surgery may be detected,quantified, and corrected. Such quantified movements are then used toadjust the target abduction and anteversion angles of the acetabularcup.

In some embodiments, a sterile surgical bag may be used to enclose thegyroscopic unit(s) to allow them to be situated within the operativefield.

In further embodiments, employing the use of a portal incision remotefrom the main incision to permit precise acetabular bone preparation andcup implantation while employing a minimally invasive surgical approach,the proper placement of the portal incision is determined using aninside-out technique by using the geometry of the acetabulum to direct apath along a trajectory extending out from the plane formed by the faceof the acetabulum to a point on the skin that provides perpendicularaccess to the acetabulum.

To assist with proper femoral bone preparation and implantation, otherembodiments may involve using a laser pointer or other positioningdevice to more accurately verify that the femoral broach is properlyaligned with the femur while the surgeon is preparing the femur toreceive the femoral prosthetic. The laser pointer may create a visibleline or spot projecting generally parallel to the line of attack of thefemoral broach. This permits more precise targeting of acceptedanatomical landmarks such as the center of the popliteal space.

BRIEF DESCRIPTION OF THE DRAWINGS

Some elements in the drawings have been drawn not to scale so thatdifferent features can be shown with better clarity.

FIG. 1 is a front view of an X-ray image of the pelvis showingacetabular components on both sides of a patient in a prescribed rangeof abduction angles as discussed above for long-term wear and jointstability in keeping with one embodiment of the present invention.

FIG. 2A is a perspective view of a tubular member in keeping with oneembodiment of the present invention utilizing a directional device whichis directed toward the center of the acetabulum, trial cup, orattachment end of an acetabular component placement tool, as discussedbelow, so that the directional device may reliably point the tubularmember away from the acetabulum along a path that is generallyperpendicular to the plane defined by the face of the acetabulum. Thecutting member may thereby be directed through the tubular member andoutward to the patient's skin where the portal incision will be madeeffectively at the optimal location, thereby creating access to theacetabulum along this path through the newly created portal incision.

FIG. 2B is a diagram of a tubular member in keeping with anotherembodiment in keeping with the present invention in which the turnradius is minimized to reduce the size of the cross-section necessaryfor the tubular member.

FIG. 2C is a perspective view of another embodiment of a tubular memberthat does not require a flexible tool.

FIG. 3 is a diagram of an embodiment showing the tubular member placedthrough a main incision in which the directional device assists thesurgeon by pointing to the middle of the acetabulum (or trial cup, asdiscussed below, not shown). The cutting member thereby optimally takesa path generally perpendicular to the plane defined by the face of theacetabulum while allowing the surgeon to avoid critical blood. Note, thetissue such as nerves, tendons, ligaments, muscles, fat, and the likehave been removed for clarity.

FIG. 4 is a diagram of another embodiment showing a tubular member inthe vicinity of the pelvis bone and the acetabulum.

FIG. 5 is a diagram of a trough in keeping with one embodiment in whicha trough is used instead of or in conjunction with a cannula.

FIG. 6 is a drawing showing an acetabular component placement tool inkeeping with one embodiment of the present invention inserted into themain incision with a cannula (to permit placement of, for example, anin-line impaction tool) resident in the portal incision. The side holein the handle of the acetabular component tool is shown as round, butcould readily be keyed or any other shape to ensure the properorientation of the gyroscope holder that holds the gyroscopic unit.

FIG. 7 is a perspective view of another acetabular component placementtool with a gyroscopic unit attached to the gyroscope holder in keepingwith one embodiment of the present invention.

FIG. 8 is a depiction of an acetabular component placement tool in use.

FIG. 9 is a drawing of the surgeon observing an image from a radiographyunit in keeping with one embodiment of the present invention showing onepreferred viewpoint of the radiography unit for use in combination withthe gyroscopic unit in precisely positioning the acetabular componentabout two axes, the abduction angle and the anteversion angle.

FIG. 10A is a drawing of a strike plate in keeping with one embodimentof the present invention.

FIG. 10B is a drawing of a strike plate placed within a cavity of anacetabular component in keeping with one embodiment of the presentinvention.

FIG. 11 is a drawing of another embodiment of the strike plate showing anumber of impact points to allow the selection of the appropriatelocations on the strike plate for the surgeon to tap with a tappinginstrument in order to achieve the desired movement of the acetabularcomponent in situ as it engages the bone.

FIGS. 12A and 12B are diagrams of the relatively harder and relativelysofter bone regions that the acetabular component encounters and thatgreatly add to the difficulty of precise placement and positioning ofthe acetabular component. These relatively hard and soft bone regionsoften cause the acetabular component to move in a complex path inreaction to the tapping described herein as part of one embodiment ofthe present invention. As a result, these hard and soft bone regions areone reason a strike plate having multiple impact points is particularlycritical to achieving proper orientation of the acetabular component.

FIG. 13 is a perspective view of an embodiment of a disengagement toolto remove an impaction tool.

FIG. 14A is a drawing of a smartphone being used as the gyroscopic unit.It may have an open source or proprietary gyroscope application. Theunit may then be placed in a sterile bag as shown for use during thesurgical procedure.

FIG. 14B is a drawing of a smartphone gyroscopic unit in the sterile bagof FIG. 10 wherein the bag is stretched tightly and any excess is foldedback and away from the screen so that the screen of the smartphone (oriPod or the like) remains readily visible to the surgeon and thetouch-sensitive functionality of the screen remains accessible throughthe bag membrane.

FIG. 15 is a perspective view of a second gyroscopic unit fixed to apoint on the patient's pelvis.

FIG. 16 is an image that may be produced by the combination of thepositional data from the first and second gyroscopic units reflectingthe position of the cup relative to the acetabulum and the plane definedby the face of the acetabulum during a hip replacement procedure inkeeping with one embodiment of the present invention.

FIG. 17 is a perspective view of a femoral broach handle showing anadjustable mount for a pointer alignment device extending laterally fromthe handle that can allow adjustments for anteversion rotation of thebroach and broach handle as it is inserted and to maintain a pointerdirected precisely along the true posterior or true anterior surface ofthe femur. In keeping with one embodiment of the present invention, thisalignment indicator—capable of indicating either or both of the broachlongitudinal direction and anteversion orientation—reduces the risk ofmalposition of the femoral implant which can result in incorrect sizingor femur fracture.

FIG. 18 is another perspective view of the femoral broach handle of FIG.17 in combination with a broach in place in keeping with one embodimentof the present invention.

FIG. 19 is a side view of the femoral broach handle with a laser pointerdevice attached in keeping with one embodiment of the present invention.

FIG. 20 is a perspective view of the femoral broach tool in use with alaser indicator light pointing toward the vicinity of the poplitealspace and a gyroscopic unit to read the anteversion of the femoralbroach in keeping with one embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The detailed description set forth below in connection with the appendeddrawings is intended as a description of presently-preferred embodimentsof the invention and is not intended to represent the only forms inwhich the present invention may be constructed and/or utilized. Thedescription sets forth the functions and the sequence of steps forconstructing and operating the invention in connection with theillustrated embodiments. However, it is to be understood that the sameor equivalent functions and sequences may be accomplished by differentembodiments that are also intended to be encompassed within the spiritand scope of the invention.

In general, minimally invasive techniques for total hip arthroplastyrequire making a main incision in the hip area of the patient to accessthe acetabulum of the pelvis, making a portal incision (described bythis author in prior disclosures) to facilitate the proper positioningof an acetabular component, properly positioning the acetabularcomponent in the acetabulum by making adjustments of the acetabularcomponent through the main incision and the portal incision, utilizingthe main incision to facilitate preparation of the femur to receive afemoral implant, and preparing the femur with a femoral broach toreceive the ball that will be coupled with the acetabular component. Onemajor goal is to achieve the proper abduction angle and anteversionangle as shown in FIG. 1.

One embodiment of the present invention involves an intraoperativesystem and method of locating the optimal position for the portalincision for a minimally invasive THA, properly positioning theacetabular cup, and properly preparing the femur. The portal incision insuch an embodiment, the portal incision is located by making a mainincision to access an acetabulum of a patient, using either a blunt orcutting member to forge a path through the patient's tissues along atrajectory generally perpendicular to the plane defined by the face ofthe acetabulum, thereby identifying an appropriate portal incisionlocation on the patient's skin while allowing the surgeon to avoidnumerous blood vessels, muscles, tendons, and nerves in the process,making a portal incision at this identified point on the patient's skin.Then, the surgeon may use the direct, frontal access to the acetabulumcreated by this portal incision and path to prepare the acetabulum toreceive an acetabular cup. This access may be further secured andmaintained by using a cannula, trough or spatula device. In suchinstances, the surgeon may introduce the device to maintain the channeland thereby protect the contiguous tissues from additional injury byplacing the device around the tip of the blunt or cutting member andthen guide the trough-like device through the portal incision in intothe forged path.

In some embodiments, the acetabular component or cup may then beproperly positioned to greatly improve the likelihood of success andlongevity of the component, including attaching the acetabular cup tothe end of an acetabular component placement tool and using theacetabular component placement tool to place the cup in roughly thecorrect position with respect to the pelvis of the patient. Knowing theapproximate position of the patient's pelvis by virtue of the use of atleast a semi-secure positioning device, the surgeon may then take afirst abduction and a first anteversion reading using a gyroscopicpositioning unit aligned with the acetabular component placement tool.The surgeon may then use a radiography unit to take an image of thepelvis containing the newly placed cup and use this image to moreaccurately determine the position of the cup.

In light of this true initial position, the surgeon may then alter theposition of the cup incrementally by using a striking tool to tap acontact surface at one or more preformed impact receiving points,wherein the contact surface is in mechanical communication with the cup.The surgeon may taking new abduction and anteversion readings todetermine the how far the cup moved relative to the initial position dueto the tapping, and then repeat the tapping and reading steps until thecup has reached a proper abduction angle and anteversion angle asindicated by the gyroscopic device display. The proper position for anacetabular cup is defined as a position in which the abduction andanteversion angles are within the predetermined acceptable ranges, asdiscussed above and widely researched in the literature.

This method indeed, among other benefits, allows the surgeon to properlyposition the cup without having to place any positioning pins in or onthe patient, thereby avoiding the pain, risk of infection, and risk ofpin movement that may accompany the use of positioning pin. Thistechnique also eliminates the use of line of sight transmitters, e.g.,RF type, which can be disrupted during the typical movements ofpersonnel in and around the operative field, or by blood contacting thetransmitters, or the computer crashing.

In some embodiments of the present invention, the femur may be preparedby a femoral broach mounted to a broach handle that involves a strikingpost and a straight-line pointer means. The means could be a light orlaser pointer on an adjustable mount that is mounted on the handle toallow moving the pointer around, toward or away from, and/or along thehandle or striking post. It can be locked into place once properlypositioned to point along an optimal line, such as along the back of thepatient's thigh generally toward or medial to the popliteal space of theknee. The surgeon then observes that the pointer continues to point atthe chosen target in the direction of this chosen line while he or sherepeatedly strikes the broach handle or striking post, thereby ensuringthat the femoral broach itself is properly oriented and aligned with thefemur.

I. Positioning the Portal Incision

In one embodiment of the present invention, the surgeon locates theoptimal position for the portal incision 244 by cutting from the insideout, or from within the main incision, along a trajectory away from theacetabulum 202 perpendicular to the plane defined by the face of theacetabulum. This technique allows the surgeon to locate a safe internalstarting point and a safe path directed out to the under surface of thepatient's skin better avoiding certain critical structures (veins,arteries, tendons, muscle, sciatic nerve, other nerves), forging a safepath or course around these structures while “sighting” or directingfrom inside or from within the main incision 242. Then, once thestarting location is identified adjacent to these critical structures asobserved by the surgeon through the main incision 242, a rigid, sharp orblunt or generally tubular body 100 is inserted adjacent to and withoutdamaging these structures. The body 100 may be either curved as shown inFIGS. 2A and 2C, or angled as shown in FIG. 2B. In some embodiments, thebody 100 is generally tubular and a flexible tool 108 is passed throughthe hollow of the body and used to cut a path in the direction of theskin 240 distal to the main incision 242 to create an acetabular portalincision 244 from the inside out. In other embodiments, the body 100itself has a sharp or blunt front end that may be used to cut or forge apath in the direction of the skin 240 distal to the main incision 242 tocreate an acetabular portal incision 244 from the inside out. In bothscenarios, the path may be forged adjacent to and without damaging thesecritical structures in a manner best achieved in this inside-out method.

That is, by contrast, existing methods generally establish a locationfor the acetabular portal incision from visual cues or measurement madeexclusively outside of the patient's body. With such outside-in methods,however, a trajectory is created and forged in which the surgeon cannotreadily observe and avoid these critical structures in order to alterthe path to accommodate variations in anatomy. These methods, therefore,typically cause the surgeon to risk encountering critical blood vessels,muscles, tendons, and nerves. Severing any of these can cause seriouscomplications and unnecessary bleeding. Indeed, most outside-in methodslend to misjudging the proper location of the portal incision due to theinaccuracies in the rotational orientation of most common externalvisual guides. This error in rotation can even lead to perforating thefemur anteriorly or piercing the sciatic nerve posteriorly. All of thismay be avoided by the several inside-out methods described herein inkeeping with the present invention.

In one embodiment of the present invention, therefore, a tubular body100 is equipped on one end with a linear sighting or directionalmechanism 104 to maintain a trajectory generally perpendicular to theplane P of the face of the acetabulum 202. As shown in FIG. 2A, in apreferred embodiment, the tubular body 100 is a hollow rod having afirst portion 101 with a first opening 103, a second portion 102adjacent to the first portion 103, the second portion 102 having asecond opening 107 in communication with the first opening 103, and abend 109 connecting the first and second portions 101, 102. In otherwords, the first portion 101 bends into the second portion 102.

The first portion 101 of the tubular body 100 is generally cylindricaland straight defining a first axis A and may serve as a handle. Thefirst opening 103 may be positioned at or near the top or terminal endof the first portion 101 opposite the second portion 102. In someembodiments, the first opening 103 may be on the side surface of thefirst portion 101. In some embodiments, the first opening 103 of thetubular body 100 may be on an auxiliary shaft 111 protruding outwardlyfrom the first portion 101 at an acute angle. In some embodiments, thefirst portion may comprise multiple openings for the surgeon to choosefrom.

The second portion 102 allows the tubular body 100 to be properlypositioned adjacent to the acetabulum in order to identify and create apath towards the location of the portal incision 244. The second portion102 comprises a lead 115 and a directional tool 104 coaxially alignedwith the lead, the lead and the directional tool defining a second axisB. In some embodiments, the lead 115 comprises a second opening 107perpendicular to the second axis B. Due to the bend 109, the first axisA and the second axis B are non-parallel to each other. In someembodiments, the first axis A and the second axis B may form an acuteangle with each other. In some embodiments, the angle between axis A andaxis B is between 25° and 75°, in a preferred embodiment this angle iswithin the range of 35° and 65°. In some embodiments, the angle betweenaxis A and axis B may be greater than 90° but less than 180° as shown inFIG. 2C. This directs any tool traveling parallel to or along the secondaxis to move towards the surface of the skin 240 when the tubular bodyis properly placed in the main incision 242.

In some embodiments, the bend 109 creates a tubular body 100 having anoverall “J”-shape or hook-shape appearance as shown in FIGS. 2A and 2B.Due to the small amount of space afforded by the main incision in suchsurgeries, in some embodiments, the bend 109 may have a tightercurvature giving the external appearance of the tubular body more of a“T”-, “L”-, or “V”-shape as shown in FIG. 2C.

That is, preferably, the main incision should be made as small aspossible. Therefore, utilizing a tubular body 100 with a “tight” bend109, such as in the “V”-shaped embodiment in FIG. 2C, would minimize theoverall lateral dimensions, or width, of the tubular body 110; thereby,allowing for a smaller main incision. With a “tight” bend, however, aflexible tool 118 may need to be particularly flexible to make the turnas easily as in a hook shaped bend. Therefore, the back wall of the bend119 may instead have a rounded or curved shape, gradually turning awayfrom the directional tool 114 and up toward the second opening 117 toguide the flexible tool 118 to make the turn at the bend 119 and proceedtowards the second opening 117.

The tubular body 100 may further comprise a directional tool 104attached to the second portion 102 in a way that it defines a line ofsight or a trajectory that is parallel to the second axis B. In otherwords, the lead 115 and the directional tool 104 are coaxially aligned.In some embodiments, the trajectory is along the second axis B as shownin FIGS. 2A and 2B. In another embodiment, the middle of the trial cupor the middle or the backside of the attachment portion of theacetabular component placement tool may comprise a feedback mechanism tofacilitate this sighting by the directional tool 104 of the tubular body100 and ensure that the tubular body 100 was in the correct position.

Alternatively, the directional tool 104 could be a laser pointingdevice, emitting a visible laser light 106 or the like. In someembodiments, the directional tool 104 may emit laser light 106bidirectionally. For example, the directional tool 104 may be acylindrical device emitting laser light 106 from both ends in oppositedirections but along the same path. One end of the directional tool 104could then emit a laser light 106 pointing to the middle of theacetabulum 202, the middle of the trial cup that the surgeon may use forsuch positioning purposes, or the backside of the attachment portion ofthe surgical tool 300 that attaches to the trial cup and holds it inplace for such positioning purposes.

In such an embodiment, the opposite end of the directional device 104would then emit a laser light 106 along the trajectory to illuminate asafe path to the portal incision 244 location. Alternatively, the safepath may be illuminated by a lighting device that is fed through thehollow of the tubular body 100, such as an optical fiber or the like,and an imaging device may similarly be fed through the tubular body 100.

In some embodiments, the directional tool 104 is configured to beremovable from the tubular body 100.

Due to the hollowness of the tubular body 100, the tubular body 100 canreceive a flexible tool 108 via the first opening 103 that can be fedthrough the first portion 101, to the second portion 102, and out thesecond opening 107. Therefore, a diameter of the flexible tool 108 issmaller than a diameter of the first and second openings 103, 107. Asthe flexible tool 108 exits the second opening 107 it follows the pathof the trajectory established by the directional tool 104 parallel to oralong the second axis B. The flexible tool 108 may comprise a cuttinginstrument 150 at one end to cut through non-critical tissues or moveaside the critical tissues to create a path towards the skin 240 wherethe portal incision 244 is to be made. In some embodiments, the flexibletool 108 may have a blunt end.

In addition, the flexible tool 108 may be a guide wire that traversesthe path established by the trajectory towards the portal incision 244while bypassing the critical tissue. A cannula, scoopula, sleeve,spatula, or similar guide tool 120 can be passed over or along the guidewire to maintain the path access to the acetabulum and/or to put theguide tool 120 in the proper position and orientation relative to theacetabulum for performing other techniques in the surgery withoutdamaging critical tissue. In this embodiment, a cannulated, blunt, orsharp trocar, preferably approximately 8-10 mm in diameter, or othersuitable tissue-protecting sleeve can be passed over this guide wire.

The flexible tool 108 can feed through the tubular body 100 and cutthrough the subcutaneous tissue and simply tent the skin 240, therebyidentifying the portal location 244. While the skin 240 is tented, anapex is created and a 1-1.5 cm incision is made at this apex.Alternatively, still in keeping with the present invention, the surgeonmay prefer to select a feed-through cutting member that is sharp enoughand rigid enough such that the cutting member itself could actually cutthrough the skin at this optimal incision point 244.

The cutting member 150 may then be fed through the skin a shortdistance. This tubular body can be proportioned so that a 4-12 inchcannula 121, or a trough 120 as shown in FIGS. 3-5, can then be placedover its tip at a distance of about 1 cm (or enough to hold it in place)and the cannula 121 can then be led through the same safe soft tissuepath thus avoiding veins, which in the common outside-in approach aretypically severed and cause unnecessary bleeding. In such embodiments,the tip 124 or cutting member 150 of the flexible tool 108 may have adiameter that is slightly smaller than the diameter of the remainder ormain body of the flexible tool 108 so that the junction where the mainbody transitions into the tip 124 defines a rim or ledge 122 extendingradially outward from the outer surface of the tip 124, as illustratedin FIG. 3.

The flange or ledge 122 may be slight, approximately 0.5 mm, forexample, and may be located about 1 inch or more or less from the freeend of the tip 124. The cannula 121 can be placed over the pointed tip124 as it penetrates the skin 240 or otherwise passes through the portalincision until the cannula or spatula reaches the ledge 122. The sharpedges of the thin metal or plastic spatula or cannula 121 will therebybe covered as it is drawn through the soft tissue pathway defined by theflexible tool 108.

In another embodiment, the working cannula can also simply be fed over asmooth trocar that is directed along the safe trajectory towards theskin. The skin is then tented, and an incision is made to permit thetrocar to be accessible for mounting of and guidance of the cannula,spatula, or trough. In yet another embodiment, the flexible tool 108 maybe a thin-walled cannula or tissue-protecting sleeve, such as having awall thickness of approximately 1-3 mm, an outer diameter ofapproximately 8-12 mm, and a length of roughly 10-40 cm. In this way,the cannula or trough member that maintains the just created path foruse in preparing the acetabulum may be introduced from the inside out.

In some embodiments, the tubular member 100 is indeed not hollow butsolid instead, as illustrated in FIG. 2C, having its own pointed orblunt tip 126 projecting from the lead 115 that may be used to forge thepath along the generally perpendicular trajectory. The second end 102 ofthe member 100 may then have a ledge 128 between the lead 115 and thetip 126 that may then receive the end of the cannula or spatula member120 and thereby act as a cannula introducer in a similar manner asdiscussed above. In some embodiments, the ledge 128 of the second end102 may taper towards the tip 126. In such an embodiment, the main bodyof the second end 102 may have a diameter that is slightly larger than acannula, scoopula, spatula, sleeve, or similar type of guide tool 120and the tip 126 may have a diameter that is smaller than any guide tool120. This allows any guide tool 120 to slip over the end 126 and stopwhere the opening of the guide tool 120 is substantially the same sizeas the diameter of the second end 102 (i.e., at the ledge 128). In thissense, a single second end 102 can be used for different guide tools 120having different sizes.

As mentioned above, the fixed trajectory created by the outside-intechnique does not afford the surgeon with the opportunity to observecritical tissues and critical variations in anatomy or a misjudgedanteversion orientation of an externally fixed sighting guide, all ofwhich is avoided by the inside-out technique disclosed herein withreference to one embodiment of the present invention.

That is, this novel inside-out approach in this embodiment of thepresent invention allows the surgeon to actually see these vitalstructures from within and direct the potentially damaging hook ortrocar through less vital tissues, such as fatty tissues, andparticularly away from and around the vital structures and tissues. Thisvisualization of the soft tissue environment can be additionallyfacilitated by optical fiber illumination and/or digital imaging of theenvironment to determine the alternative paths through the soft tissuealong the trajectory generally perpendicular to the plane defined by theface of the acetabulum. In one embodiment, the illumination and imagingfibers can be passed through the cannulated hook. The fiberoptic lightmay also illuminate the skin from the inside out to indicate where tomake the portal incision. The incision can be made on the brightestportion of the skin.

In some embodiments, the second portion 102 or 130 of the tubular body100 or 110 may further comprise a joint or a hinge 112 or 125 to connectthe first portion 101 to the second portion 102. The hinge 112 or 125allows the directional device 104 or 114 and the lead 115 or 127(together defining axis B) to tilt in such a way so as to change theangle between axis A and axis B. The tilt of axis B relative to axis Amay be controlled by a control mechanism 113 or 129 to adjust the secondportion 102 relative to the first portion 101. Preferably, the controlmechanism 113 or 129 is a dial located at the top of first portion 101or 132 of the tubular body 100 or 110 opposite the second portion 102 or130. The control mechanism 113 or 129 may also have a locking mechanism(not shown) to lock the directional device 104 or 114 in place once theproper angle has been established. The locking mechanism may restrict orprohibit the movement of the control mechanism 113 or 129.

In other embodiments, the surgeon may tilt the first portion 101 or 132of the tubular member during the procedure to manipulate the blunt orcutting end through the soft tissue and create the optimal path. In suchembodiments, the surgeon may be able to continuously or periodicallyadjust the directional device 104 or 114 using the control mechanism toinsure that the blunt or cutting end 150 continues to travel along thetrajectory generally perpendicular to the face of the acetabulum.

The control mechanism 113 or 129 may utilize a connecting device (notshown), such as a flexible cable, rigid cable, rod, and the like, tooperatively connect to the directional device 104 or 114, the lead 115or 127, and/or the hinge 112 or 125. Movement of the control mechanism113 or 129 can increase or decrease the length of the connecting deviceso as to cause the directional device 104 or 114 and the lead 115 or 127to tilt. Use of the control mechanism 113 or 129 allows the surgeon tomake very precise adjustments to the directional device 104 or 114 so asto point the directional device 104 or 114 to the center of theacetabulum 202 with minimal movement of the tubular body 100 or 110.

II. Positioning the Acetabular Component

As discussed above, proper positioning of the acetabular component 400is critical for the prosthesis to function up to its capacity, butcurrent methods are inaccurate, risky, and time-consuming. An acetabularcomponent 400 may be any device designed to fit inside the acetabulum ofa patient. By way of example only, an acetabular component 400 maycomprise a cup, a trial cup, a reamer, a strike plate, and the like.

In one example, an acetabular component placement tool 300, such as thestandard cup holder/alignment guide shown in FIGS. 6 and 7, is commonlyused in the medical profession to place and/or align the acetabularcomponent 400 in the typical “best guess” position. Historically,because of the time consuming and technically challenging nature ofobtaining an intraoperative x-ray, the true position of the componentwas not known until a recovery room, or office, x-ray was taken. Thegenerally achieved success rate (achieving accurate positioning) issixty percent (60%) (Rubash, et al.). Unless a very severe error wasidentified, nothing was done, and the patient carried the risk of earlyfailure of the hip arthroplasty. If the cup position was too steep, thenthe plastic bearing surface could see excessive load and wear outprematurely, requiring corrective operation. If the angle was tooshallow, then impingement of the femoral neck on the anterior rim of theacetabulum could result in dislocation.

Using the very recent advances in imaging technology, i.e., theavailability of computer and or digital radiography, now makes itpossible to obtain an accurate intraoperative image within a fewseconds, such as approximately ten (10) seconds, to approximately onehundred twenty (120) seconds. This image (film or fluoroscopic image, orpossibly even CT or MRI) demonstrates the result of the “first try” or“best guess” position. Thus, in one embodiment, this image of thepatient's anatomy is used in conjunction with a gyroscopically enabledguide.

Having this intraoperative measurement, the surgeon now has anopportunity to make an immediate correction. At present, the sightingtechniques with the traditional “best guess” instruments required one ormore additional x-rays to confirm the correction. In addition, thetraditional instruments were not constructed to permit careful, precise,known degrees of adjustment.

The present invention offers a new method and tool incorporatingapplication for gyroscopic technology that provides a significantimprovement when compared with the current sighting approach, i.e.,sight, guess again, repeat the x-ray, and even possibly requiring thatthese steps be repeated again.

The present invention also eliminates significant cost, a criticalfactor in today's health care system. There is no pre-operative CT scan,avoiding potentially damaging radiation exposure, especially in youngerpatients and particularly women of childbearing age. There is no upfrontcost to the hospital in the form of capital investments of up to amillion dollars or more, there is virtually no disruption of the desiredworkflow as the required intraoperative image can be obtained in undertwo minutes, interpreted in less than thirty seconds, and can be actedupon immediately thereafter.

In the preferred embodiment, a gyroscopic unit 402 may be placed in asterile holder/container and affixed to a surgical tool 302, such as astraight or carefully angled cup holder/alignment guide, as illustratedin FIG. 7. This upgrades the traditional directional device to a meteredtool providing improved estimates during initial positioning of aprosthesis. An intra-operative radiographic image of the then-presentposition is achieved during initial estimated placement. Theradiographic measurement is then used as part of the method forachieving successful positioning or the basis for making anintra-operative adjustment. Now, upon obtaining measurements from thegyrometer and an image from the intra-operative radiographic unit, the“best guess” positioning of the acetabular component 400 relative to theacetabulum 202 can be improved, the desired positioning can bedetermined and quantitated as to the correction required for properplacement of the acetabular component within the acetabulum.

In order to improve the accuracy, reduce the risk, and work efficiently,besides the proper positioning of the portal incision 244, someembodiments of the present invention utilize gyroscopes removablymounted on surgical tools 302 involved in acetabular componentplacement, referred to as an acetabular component placement tool 300, toprovide a metered approach for adjusting the acetabular component in theacetabulum. Examples of surgical tools 302 that can be used in thepresent invention include, but are not limited to, a trial cup holder, acup holder/alignment guide, an impaction tool, a reamer unit, and thelike.

In general, an acetabular component placement tool 300 comprises asurgical tool 302 used in positioning the acetabular component 400, anda gyrometer or gyroscopic unit 402. The surgical tool 302 has a proximalend 304 connected to a distal end 306. The proximal end 304 is the enddirectly attached to or directly associated with the acetabularcomponent 400. The distal end 306 is the end that the surgeon can graspto move the tool 302 in order to adjust the acetabular component 400.The distal or upper end 306 may comprise a handle 308 to facilitatemovement of the surgical tool 302.

In the preferred embodiment, a gyroscope 402 may be attached to thedistal end 306. In some embodiments, the gyroscope 402 may be attachedto the handle 308. It is anticipated, based on the cost of gyroscopictechnology, that only a nominal cost is required to add such a meteringsystem, i.e., the “gyrometer,” to many existing surgical instrumentswith only minor modifications. Indeed, in some embodiments, a singlegyroscope 402 may sense and display the angular orientation of theacetabular component 400 in two or all three of the traditional three(X, Y, and Z) planes. In other embodiments, two or three separategyroscopes 402 may be employed to sense and indicate the angularorientation of the acetabular component 400 in each of the two or threeorthogonal metered planes, separately. In this way, the surgeon can feelfurther assured that each sensor will most accurately detect theorientation or relative orientation within the chosen metered plane(e.g., the Y plane), exclusive of any movement in either of the twoother planes (i.e., the X and Z planes).

In some embodiments, the gyroscope 402 may be integrally formed with thesurgical tool 302. In other embodiments, the gyroscope 402 may beremovably mounted to the surgical tool 302 using a gyroscope holder 404.The gyroscope holder 404 may be an elongated rod having a first end 408that attaches to the surgical tool 302 and a second end 410 opposite thefirst end 408 that attaches to the gyroscope 402. The surgical tool 302may comprise a plurality of holes 406 at different levels. The holes 406can be of any shape so long as the gyroscope holder 404 has across-sectional configuration keyed to fit into the holes 406 securely.For example, the holes 406 may be triangular, rectangular, hexagonal,star-shaped, circular with a notch, and the like. One end 408 of thegyroscope holder 404 would then have a cross-sectional shapecorresponding to the shape of the hole 406 so as to fit tightly andsecurely into one of the holes 406 without being able to rotate. Thisallows the surgeon to attach a gyroscope 402 to the surgical tool 302 insuch a way as to view the gyroscope readings. Adjustment of the holder,and thus the gyroscope, could also be carried out in order to facilitatea “zeroing effect,” creating a true read-out rather than a relativenumber.

In some embodiments, the gyroscope 402 may be incorporated in aconventional mobile electronic device 1000 containing a gyroscope 402,such as a smart phone, iPod touch, iPhone, personal digital assistant,and the like as shown in FIGS. 14A and 14B. These common mobileelectronic devices can be installed with an application for convertingthe yaw, pitch, and tilt or roll of the gyroscope 402 into the abductionand anteversion of the acetabular component 400, and the tile of thepatient's pelvis.

The gyroscopic unit 402 may be a gyrometer, inclinometer, accelerometer,magnetometer or compass, inertial sensor, GPS (Global PositioningSystem) unit, or an optical, infrared, or RF sensor. A gyroscope orgyrometer may be preferred in some embodiments in that such units oftenmeasure relative movement in two or three dimensions and in that manycommercial devices have gyrometer units that can provide high-resolutionmeasurements.

The gyroscope 402 can measure its relative position in three-dimensionalspace. Thus, any movement in the X, Y, and Z direction can be read bythe gyroscope 402. When the gyroscope 402 is attached to a tool or apatient's hip or thigh, one or more reference angular readings of thetool or patient in three-dimensional space may be communicated to thesurgeon by the gyroscope 402 to monitor any movement of the patient'spelvis. When associated with a smart phone or other computing device,the gyroscope 402 can display, announce, or otherwise indicate itsrelative position. The surgeon can set the initial position as theorigin and calculate the amount of deviation from the origin necessaryfor correct positioning and move the surgical tool attached to thegyrometer 402 until the proper readings are reached. Alternatively, thecorrect positioning may be established as the origin and the gyrometer402 may indicate the amount of deviation from the origin. Therefore, thegyrometer 402 can be moved until its readings reflect that it hasreached the origin.

As mentioned above, in some embodiments, a gyroscopic unit 402 may besuperior to a standard inclinometer or magnetometer. A standardinclinometer allows angular readings and correction relative to only thevertical axis. This single reading by itself cannot correctly positionthe acetabular component 400 to minimize wear and reduce risk ofdislocation. Similarly, a magnetometer typically allows angular readingsonly relative to a near-linear magnetic field, such as the Earth'smagnetic field. The dual-axial or tri-axial reading from the gyroscopicunit 402, by contrast, can inform the surgeon as to the relativemovement of both the abduction angle (in a first plane) and theanteversion angle (in a second plane perpendicular to the first plane),as well as the tilt of the pelvis (in the third and remaining orthogonalplane).

Additional precision can be achieved if the pelvic tilt is controlled.The holder may also have a hinge 702 and set screw 704 so that thesurgeon may “zero” the anteversion angle reading simply be adjusting thehinge 702 and then tightening down using the set screw 704 when theanteversion reading is just as the surgeon prefers. Examples of suchhinge 702 and set screw 704 are illustrated in FIG. 7.

In the preferred embodiment, the gyroscopic unit 402 may be enclosed ina container 1002 to reduce and/or eliminate cross-contamination betweenthe gyroscopic unit 402 and the patient. For example, the gyroscopicunit 402 may be wrapped inside a sterile bag. This also makes cleaningand reusing the gyroscopic unit 402 easy.

In yet another example that is still in keeping with some embodiments ofthe present invention, two or more gyroscopes 402, 403 may be used foradditional reference points to compensate for movement of the patient'sbody, or the pelvis, rather than the movement of the acetabularcomponent 400. For example, a second gyrometer 403 may be used as asecond reference point. The second gyrometer 403 may be mounted to apoint on the patient's anatomy, such as a point on the patient's pelvis200, with a rod (not shown) or some other type of holder that wouldfacilitate proper positioning of the acetabular component 400. In someembodiments, the second gyrometer 403 may be attached directly to thepatient's anatomy without a rod, for example, with an adhesive thatwould still permit the surgeon to read the second gyrometer 403. Thedirect attachment may be removable so as to remove the second gyrometer403 when the surgery is complete. The surgeon may then be able to verifyto what degree the patient's pelvis 200 has moved since the initialreadings were taken from both the first and second gyrometers 402, 403.The surgeon may then use this degree of movement of the pelvis 200 torecalibrate the first gyrometer 402 or otherwise take such adjustmentsinto account when calculating his or her target readings on the firstgyrometer 402, which, in combination with the readings from the secondgyrometer 403, is reflective of the position of the acetabular component400 in relation to the acetabulum 202 of the patient's pelvis 200. Insome embodiments, first and second gyrometers 402, 403 may be incommunication with each other so that the first gyrometer 402 receivesthe readings from the second gyrometer 403 and the first gyrometer 402displays its readings regarding the positioning of the acetabularcomponent 400 after compensating or adjusting for the movement of thepelvis as determined by the second gyrometer 403.

In some embodiments, the two gyrometers 402, 403 may communicate witheach other or with a local computer 800 so that the changes in targetreadings of the first gyrometer 402 (i.e., the target position of theprosthetic cup) may be tracked, communicated, and even displayed on amonitor 802 to indicate to the surgeon how the patient's pelvis mayshift during the procedure. As shown in FIG. 16, computer software cantransform the readings and radiographic image of the actual, relativeorientation of the acetabulum 202 and acetabular component 400 into atwo- or three-dimensional image representation of the cup 300′;acetabulum 202′; and plane 203′ defined by the face of the acetabulumcombination and display it on a screen 802 either on one of thegyrometer units 402, 403 or on the local computer 800 in real time sothat the surgeon may get a good sense of how the acetabular component400 is located and moving relative to the acetabulum 202 during theprocedure as the surgeon moves the acetabular component 400 in at leasttwo dimensions relative to the acetabulum 202 (i.e., in the abductionand in the anteversion directions) and as the patient's acetabulum 202itself may move in any direction during the procedure.

In some embodiments, instead of, or in addition to, displaying thereadings of the gyrometer 402, the gyrometer 402 may announce thereadings orally, or use a tone or some other aural indicator, so thatthe surgeon does not have to take his eyes of the patient to read thegyrometer 402. The gyrometer 402 can announce either the currentlocation so the surgeon knows where he needs to move the acetabularcomponent 400, or the gyrometer 402 can announce the type of movementsthe surgeon needs to make the properly position the acetabular component400.

Minor adjustments may be made with an impaction tool 600, such as astrike plate as shown in FIGS. 10A, 10B, and 11. An impaction tool 600is configured to protect the acetabular component 400 as the acetabularcomponent is being struck for proper positioning. In some embodiments,the impaction tool 600 may comprise multiple striking ports 700, such ascorrugations, dimples, depressions, divots, recesses, and the likeimpaction surface on the inside 602. The outside surface (not shown) ofthe impaction tool 600 contacts the inside of the acetabular component400 and creates a high-friction contact. Due to the high friction,movement of the impaction tool 600 causes movement of the acetabularcomponent 400. Therefore, small increments of precise adjustment of theacetabular component 400 can be made by tapping on the impaction tool600 without damaging the acetabular component 400. Such precise andincremental movements are critical, particularly because of thecombination of hard and soft bone surfaces that the acetabular component400 must engage with and seat into. The impaction tool 400 also, in someembodiments, may have regions through which the surgeon may see throughto the bone to confirm that the cup is fully seated.

In some embodiments, the impaction tool 600 may be a total contact shellmating with the inner concavity of the acetabular component 400 andsecured via a central screw. The exposed surface of this shell presentsmultiple striking ports 700 on the inner face 602 to assist with fineadjustments of abduction or anteversion as the acetabular component 400is seated. The surgeon may alternately strike the off center ports 700and then the central port, depending upon the changing position of theprosthesis as it is seated. It is important to appreciate that the bonedensity typically varies around the rim, along the walls and at the domeof the prepared acetabulum as shown in FIGS. 12A and 12B. For example,the acetabulum may have hard areas 900 and soft areas 902. Because ofthis variability, the prosthesis, if not monitored and controlled as itis seating, will follow the course of least resistance. Following thatcourse creates a high risk of component malposition. Traditionalpositioners provide only for a central striking surface and a handle togenerate a rotational force at a point removed from the implant itselfand therefore not as precise as needed. The latter, central strikingonly technique, typically requires disengagement and re-engagement asthe cup approaches final seating. This allows for the possibility oflosing some pressfit as the bone is compressed with the first seatingand then can lose some “stiction friction” or press fit upon reseatinginto the newly compressed bone.

In some embodiments, the impaction tool 600 may further comprise aflange 608 at the opening of the impaction tool 600. The flange 608 canbe one continuous ring around the open edge of the impaction tool 600parallel to and in the plane of the strike plate opening. Alternatively,the flange 608 may be short segmented flanges intermittently spacedapart around the edge of the opening. These flanges 608 can furtherserve as striking points to permit greater angular momentum for movingthe actual acetabular component 400. In some embodiments, the flanges608 may comprise striking ports 700, such as dimples, recesses, divots,depressions, corrugations, or other modifications to facilitate strikingof the impaction tool 600. The striking elements in all cases aresituated and construed in a manner that protects the surfaces of theacetabular prosthesis.

In some embodiments, the surgeon may tap the flange 608 with theimpaction tool 600 while the elongated handle remains attached to theacetabular component. In other embodiments, the surgeon may remove theelongated handle so that the surgeon may have numerous other strikingports 700 to select to tap with a striking tool (not shown). In such anembodiment, the strike plate or acetabular component 400 can have akeying surface, such as one or more component keying features 605, sothat the surgeon may quickly and easily re-seat the elongated handlewithin the acetabular component 202 from time to time to take newabduction and anteversion readings from the gyroscope 402.

For example, the component 202 may also be keyed, such as with one ormore matching keying members 405, to mate with the keying surface of theimpaction tool 600 in order to re-seat the proximal end 304 of the tool300 in an identical orientation. The gyrometer holder may also be keyedin order to re-seat it in an identical orientation.

In some embodiments, a disengagement tool 1300 is provided for thesurgeon in case the acetabular component is so firmly impacted thatsimply striking off center will not result in the desired repositioningand may get stuck in the hard and soft bone material 900, 902. That is,surgeons may find the cup or other component may get stuck or frozenwithin the acetabulum making it difficult or nearly impossible to adjustthe component any further. The surgeon may then use the disengagementtool 1300 shown in FIG. 13 to carefully and minimally, in a controlledmanner, pry the component, such as the impaction tool 600, loose so thathe or she may then re-institute the routine described above in a furtherattempt to properly position the component using the radiographic unitand/or the gyroscopes.

The disengagement tool 1300 may comprises a handle 1302 and an arm 1304attached to the handle 1302. At the end opposite the handle 1302, thearm 1304 may branch or fork into multiple prongs. The impaction tool 600may comprise a plurality of fenestrations 604. A first prong 1306 may beconfigured to engage a first fenestration. A second prong 1308 may bebent at an angle relative to the arm 1304 and/or the first prong 1306 soas to engage a second fenestration. In some embodiments, the first andsecond prongs 1306, 1308 may be configured so that the first prong 1306can engage the first fenestration while at the same time the secondprong 1308 is able to engage a second fenestration. This can improve theleverage of the disengagement tool 1300 to more easily remove theimpaction tool 600. To further improve the leverage, additional prongsmay be added, one or more of the prongs may be adjustable or extendableto accommodate a number of feature configurations on the accessiblesurface of the impaction tool 600. In some embodiments, thedisengagement tool 1300 may be configured to engage the striking ports700 to remove the impaction tool 600.

The handle 1302 may be any shape. In some embodiments, the handle 1302may be planar. A planar surface could provide a striking surface tocontrollably move or remove the impaction tool 600. In some embodiments,the handle 1302 may comprise contours so as to be ergonomically shapedto facilitate grasping of the handle 1302.

Example 1

Generally, when using an acetabular component placement tool 300, startwith the “Best Guess” approach (using the traditional “Sighting” Guideapproach, plus the Cup Holder/Alignment Guide), obtain a radiographic orfluoroscopic image, and then use one embodiment of the present inventionto make precise adjustments.

For example, once all of the proper incisions have been made and theacetabular components 400 is initially put in place with an acetabularcomponent placement tool 300, the present settings of abduction andanteversion are read from the gyroscopic device 402. An imaging device804, such as those used in radiographic or fluoroscopic imaging, can beused to create a radiographic or fluoroscopic image. For example, theimaging device 804 may be an x-ray machine emitting x-rays 806. From theradiographic imaging, the degree of abduction and anteversion needed forproper placement of the acetabular component 400 can be determined.Then, as the acetabular component placement tool 300 is shifted in thedesired direction(s), the gyroscopic device 400 displays the real timechanges in degrees so that the surgeon knows how much movement has beenmade, and how much more movement in a particular direction is stillrequired. This reading, in reference to the starting position, gives thesurgeon precise affirmation that the ideal position for stability anddurability has been achieved.

The application of the gyroscopic indicator offers a reading, anumerical equivalent, that records the position in space thatcorresponds to the instant positioning confirmed on x-ray. Thecorrection can then be made. Precise adjustments in the two criticalplanes (abduction and anteversion) can now be guided by observing thegyroscopic readout. For example, the readout can be calibrated to theamount of correction desired in each plane and noted to be correct whenreading zero for abduction and anteversion. Another embodiment would beto set the gyroscope at the measured abduction and anteversion andsimply correct or change the component position to the desired readingwhich would then indicate the desired position has been achieved.

Example 2

In yet another embodiment, the best guess position can be made moreprecise by applying the present invention to the standard cupholder/alignment guide and, rather than relying on line of sight, i.e.,identifying a neutral or zeroing orientation that at present is simply“sighted” in relation to operating room structures (a corner of theroom, a vertical line of tiles on the wall, or any nearby straightvertical object) or imprecise anatomical landmarks (patient's trunk,shoulder, opposite kidney). That is to say, that the gyroscopicindicator is capable of indicating true vertical for the upright part ofthe guide and true zero or neutral for anteversion. After cup placementin the orientation directed by the combined references of the presentinvention connected (physically or remotely) to the recently redesignedalignment guide, the guide is then removed. Screws or a trial liner maythen be placed. A femoral trial may also be placed in the best guessposition either before or after placing the acetabular component. Anx-ray or fluoroscopic image is then obtained.

Those “corrected numerical” readings are used when placing the actualacetabular component. The instrumented portion of the reamer handle canthen be transferred to the standard alignment guide.

Example 3

This example is similar to Example 1 above, but including an attached“gyrometer.” The reamer basket (not shown) itself can act as a surrogatefor the acetabular component 400. The gyrometer 402 settings can then benoted, an x-ray taken, and any corrections identified by measuringangles on the x-ray. This could be considered a way of calibrating thegyrometer 402. When returned to the same position (as indicated by thesubsequent gyrometer 402 readout), correct acetabular component 400positioning is then achieved by placing the acetabular component 400 inposition, which results in corrected gyrometer readings.

By using a digital gyroscopic unit, the surgeon can quantify theorientation in space of the acetabular component greatly improving onthe “best guess” orientation in which the surgeon might otherwiseeyeball the positioning. Clinical research to date (including, Rubash,et al.) confirms a 40% error rate with current “best guess” in which thesurgeon does not use such digital sighting or directional instruments.

The combination may create an advantage, including by avoiding the needfor the unreliable “line of sight” relative referencing or the bootingand rebooting of a computer, both of which take substantial time andhave been cumbersome and unreliable. Indeed, these cumbersome andunreliable techniques have been abandoned at many centers. As stated,forty percent (40%) of the time, the position will be outside of thedesired range and a correction will be desirable. The data indicatesthat the success rate using the intraoperative imaging and adjustmentmethods of the present invention can be improved from sixty percent(60%) to almost ninety-nine percent (99%)—and this significant successrate may be produced using minimally invasive surgery procedures.

Some embodiments of the present invention also may eliminate the needfor reference pins in the pelvis as such pins can loosen, changeposition, and diminish precision. The pin sites can become infected andrequire treatment with costly and risky antibiotics. A persistent pinsite infection could result in migration of bacteria to the newprosthesis with disastrous results. While placing pins there is risk tonearby nerves and blood vessels. Numbness, weakness, or unnecessaryblood loss could occur. There is also a price to pay in terms of timeand materials. Clearly, avoiding reference pins offers a significantadvantage.

III. Positioning the Femoral Broach

In some embodiments of the present invention, the femur 220 is preparedby a femoral broach tool comprising a femoral broach 1401. The femoralbroach 1401 may be mounted to a broach handle 1400, which comprises anelongated connecting member 1402. A striking post 1403 then may beconnected either to the connecting member 1402 or directly to a portionof the femoral broach 1401 to allow the surgeon to strike the strikingpost repeatedly until he or she has displaced the appropriate amount ofbone material from the femur to leave room for the prosthesis and anyassociated mounting structures and cementing material.

The lengthwise orientation of the femoral broach 1401 during thisprocess is critical to the successful preparation of the femur 220 andultimate positioning of the prosthesis. In previous methods, the surgeonlined up either the connecting member 1402, the striking post 1403, orthe hammer itself with line of sight methods previously disclosed byApplicant in considerable detail. In short, this often entailsenvisioning the femoral broach 1401 to be in line with the striking post1403 and attempting to keep the striking post 1403 therefore in line orparallel to some straight line along the patient's leg or other straightline in the operating room that serves as a proxy to the centerline ofthe patient's femur 220.

As shown in FIGS. 17 through 20, another aspect of the present inventionis the femoral broach handle 1400 being equipped with a more precisealignment means to visibly align the femoral broach 1401 during the bonedisplacement. The femoral broach handle 1400 comprises an elongatedconnecting member 1402 defining a central axis C (which defines the lineof attack), attached to a striking surface, platform, or post 1403, tohold and drive the femoral broach 1401 into the femur, and an adjustablemount 1404. The adjustable mount 1404 is connected to the connectingmember 1402 in such a way as to allow the adjustable mount 1404 torotate about the connecting member 1402 as well as slide up and down theconnecting member 1402.

The adjustable mount 1404 comprises a post 1406 and a lock 1408 toreceive and secure a pointing device 1500, such as a laser pointer. Thepost 1406 may also be telescopic to adjust the distance of the pointingdevice 1500 relative to the connecting member 1402. Due to theadjustable mount 1404, the laser pointer 1500 may be offset from thecentral axis C of the femoral broach 1401 and connecting member 1402,and it is oriented to emit a light or laser generally parallel to thiscentral axis C. In some embodiments, the surgeon then can adjust thepositioning of the pointer 1500 so that the light emitted from it runsalong the back of the thigh approximately toward the popliteal space602, strikes the back of the thigh near the region of the poplitealspace 602, strikes the back of the calf just past the region of thepopliteal space 602, or strikes any other desired precise referencepoint that guides broach and the prosthesis orientation.

The mount 1404 for the pointer 1500 may be adjustable in a number ofways relative to the connecting member 1402 to accommodate the surgicalprocedure. In one such embodiment, for example, the mount 1404 may be acollar rotatably mounted to the connecting member 1402, such that it canbe rotated about the central axis C of the connecting member 1402. Thesurgeon may simply rotate the offset mounting arm about the central axisC of the connecting member 1402 and then fix the pointer at anappropriate angle using the lock 1408, such as a set screw or the like,to indicate the anteversion angle as the broach seeks the desiredneutral position in the femoral canal. The mount 1404 may also beslidable along the connecting member 1402 so as to adjust the distancefrom the broach 1401. The mount 1404 may also have a tilting capabilityto allow the laser pointer 1500 to be adjusted so as to be parallel tothe connecting member 1402.

In this way, the pointer 1500 may be adjusted to visibly maintain thecentral axis C in any preferred anteversion angle, regardless of theanteversion angle of the handle 1400 so that the surgeon can project thelaser light 1600 directly over the posterior or anterior femur whileorienting the broach 1401 in the same or any other desired anteversionangle. The surgeon then observes that the pointer 1500 continues topoint at the chosen target in the direction of this central axis C ofthe connecting member 1402 as he or she repeatedly strikes the strikingpost 1403 or surface of the broach handle, thereby being certain thatthe central axis C of broach 1401 itself is properly oriented andaligned with the central axis of the femur.

In one preferred embodiment, therefore, the anteversion angle of thefemoral broach may be monitored, and in fact a gyroscopic unit 402 maybe mounted to the broach handle 1400 in a similar fashion as discussedabove with respect to the handle 1400 for the acetabular component 200.As illustrated in FIG. 20, there may be a mounting arm 1407 having alock 1411 as well as a pivot means 702 and locking means 704 so that theanteversion of the broach may be zeroed intraoperatively. Furthermore, asecond gyroscopic unit 403 may be temporarily mounted to the patient'sbody, such as the thigh or knee region, as a reference reading to assistwith a precise anteversion reading for the broach 1401 even if thepatient's leg happens to move or shift during the procedure.

This is especially important when placing a cemented implant that is notguided by the prepared bone envelope. That is, the handle and alignmentmeans may hold the femoral component in the proper longitudinalalignment while the cement sets so that any forces on the femoralcomponent as the cement begins to set may be overcome by the surgeon.The surgeon may additionally wish to maintain a given anteversion anglefor the femoral component using the same handle and alignment means.

Whether employed in the setting of the femoral prosthesis or not, theanteversion readings for the femoral broach and/or prosthesis itself canbe used to calculate or modify the target anteversion range for theacetabular component 200 unique for the given patient. That is, theanteversion angle for the femoral component can fall within a widerange, ordinarily between 0° and 70°, and typically is dictated by thecontours of the patient's femur. This may be due to a number of factorsunique to each patient. As a general rule, therefore, the anteversionangle of the acetabular component normally is more easily varied thanthe anteversion angle of the femoral component.

The actual angle of anteversion of the femoral component for mostpatients can affect what is the appropriate target range for theanteversion angle of the acetabular component for a hip replacement tohave a successful longevity. Typically, the larger the anteversion angleof the femoral component, the larger the anteversion angle needs to befor the acetabular component, leading to increasing the targetacetabular anteversion angle to within a range of 20 to 25, where thepatient's femoral anteversion angle is on the higher end of theabove-mentioned range.

While the present invention has been described with regards toparticular embodiments, it is recognized that additional variations ofthe present invention may be devised without departing from theinventive concept.

What is claimed is:
 1. A tubular body for locating an optimal positionfor a portal incision in a hip arthroplasty in a patient, comprising: afirst portion defining a first axis, the first portion having a firstopening; a second portion, the second portion, comprising: a lead havinga second opening in fluid communication with the first opening; and adirectional tool, the directional tool connected to a leading end of thefirst portion, wherein the lead and the directional tool are coaxiallyaligned to define a second axis, wherein the first axis and the secondaxis are non-parallel; a flexible tool inserted through the firstopening, a leading end of the flexible tool exiting the second opening,the leading end comprising a cutting instrument, the leading endextendable away from the second opening for use in advancing the leadingend through non-critical tissues of said patient to create a path towardan optimal position for a portal incision.
 2. The tubular body of claim1, wherein a diameter of the flexible tool is larger than a diameter ofthe cutting instrument portion so as to define a ledge.
 3. The tubularbody of claim 2, further comprising a bend formed in the leading end ofthe first portion adjacent to the second portion.
 4. The tubular body ofclaim 3, wherein the bend is a tight bend to thereby form an acute anglebetween the first axis and the second axis.
 5. The tubular body of claim1, further comprising a bend formed in the leading end of the firstportion adjacent to the second portion.
 6. The tubular body of claim 5,wherein the bend is a tight bend to thereby form an acute angle betweenthe first axis and the second axis.
 7. The tubular body of claim 1,further comprising the first portion having an auxillary shaft extendingtherefrom, the auxillary shaft closer to a trailing end than to theleading end, the auxillary shaft including the first opening forreceiving the flexible tool.